Setback for Gilead hep C candidate
pharmafile | February 20, 2012 | News story | Research and Development, Sales and Marketing | ELECTRON, GS-7977, Gilead, Pharmasset
Gilead’s investigational hepatitis C drug has been dealt a blow after patients suffer relapses in a mid-stage trial.
In the Phase II trial of GS-7977, a nucleotide analogue polymerase inhibitor, the majority of hepatitis C patients in one of the study had a relapse in their disease after being treated with the drug.
The ELECTRON study showed that the majority of HCV genotype 1 patients with a prior null response to an interferon-containing regimen experienced viral relapse within four weeks of completing 12 weeks of treatment.
Ten patients were randomised to this arm of the trial and data are available for eight of the 10 patients at this time.
Gilead said that among these eight patients, six have experienced viral relapse. Two patients have not relapsed; however, they have only reached the two-week post-treatment time point, the firm noted.
This will be disheartening news for Gilead that recently paid $11 billion for the drug’s developer Pharmasset.
But Robyn Karnauskas, an analyst at Deutsche Bank issued a note saying that while the results were disappointing, a ‘disaster scenario’ was unlikely.
Gilead said the results suggest additional antiviral drugs may be necessary to effectively treat patients in this subgroup.
The firm will explore various options to treat these patients in new studies, including combinations with other orally administered antivirals.
Norbert Bischofberger, vice president of R&D at Gilead, said: “These data answer an important question about the use of GS-7977 and ribavirin for the treatment of genotype 1 null responder patients, suggesting that additional direct acting antivirals may be necessary to effectively treat this patient population.
“We will continue to explore a number of therapeutic approaches to address this significant unmet medical need, including combinations with other oral antivirals.”
The firm expects the drug to be the first all-oral regimen for hepatitis C to reach the market, potentially in 2014, and analysts have predicted blockbuster sales for the drug.
Current oral treatments include J&J’s Incivek and Merck’s Victrelis, but these must be taken along with injectable interferon treatments.
Ben Adams
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